GMP认证文件偏差中英文课件.doc

STANDARD OPERATING PROCEDURE 标准操作规程 Title?: QUALITY DEVIATION MANAGEMENT 题目：质量偏差管理 Procedure: 编号: Effective Date: 生效日期: Supersedes: 替代: Review Date: 复审日期：。 Prepared by?准备 Reviewed by审阅 Approved by批准 QA QA IQC Manager 质量部经理 Documentation that may be affected: 其他可能受到影响的文件: Out of Specification Results “OOS” 超出质量 标准结质量标准质量的实验结果 Quality Alert Management 质量警戒的管理 Change control 改变控制 Quality risk assessment 质量风险管理 Review of Corrective and Preventive Action (CAPA) Programs 纠正及预防措施的回顾 Unmodified Review History: 无变更的复审记录: Reviewed By/ Date 复审/日期 Approved by IQC Manager/ Date 质量部经理批准/日期 Next Review Date 下次复审日期 Affected Department / Area ?: 受影响的部门/ 区域?: PURPOSE 目的 Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken 当产品、物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时，必须进行适当的调查，查明原因并采取必要的改正措施。 SCOPE 范围 This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them. 本SOP适用于处理所有失误及非计划性故障事件，含概用于产品并控制产品的化学成分、包装材料、药品、工艺、系统、设备、公共设施和厂房等。 DEFINITIONS/ABBREVIATIONS 定义/缩写 Deviation（also known as anomaly）：Any unplanned change from a written procedure/document, during manufacturing or testing or a non-conformance to approved specifications or any failure on GMP-related systems. Deviations are assessed according to compliance and /or the risk they present to patient health and/or with regulatory requirements. Deviations are to be classified as “critical or major or minor” 偏差（通常也称为异常）：在药品生产过程中，任何与既定的程序、文件不符的非计划的变更或与批准的质量标准不符，或与GMP相关的系统失败。偏差按照对患者造成的风险何国家法规的符合性进行评估。偏差可分为三类“严重偏差、主要偏差、微小偏差” Critical Deviations: 严重偏差： Critical deviation